As we previously reported, Mylan recently filed a motion for judgment on the pleadings regarding Amgen’s assertion of the ’707 Patent, which covers methods related to producing the biosimilar pegfilgrastim. Mylan’s motion argued that under the claims of the patent, the salts and protein used to produce pegfilgrastim must be…
Today, AbbVie and Momenta announced that they have entered into an agreement under which AbbVie has granted Momenta a global, royalty-bearing non-exclusive license to AbbVie’s intellectual property relating to Humira® (adalimumab). According to the press releases, the deal authorizes Momenta to launch its adalimumab biosimilar, M923, in the United States…
Amgen, Sandoz, Samsung and Mylan all launched adalimumab biosimilars in Europe this past October. On October 16, 2018, Amgen has announced that its adalimumab biosimilar AMGEVITA launched in European markets. This is Amgen’s first “inflammation” biosimilar to launch in Europe, and its second biosimilar to launch in Europe overall. According to…
In August, we reported that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) recommended the granting of marketing authorization for three biosimilar medicines: (1) Fujifilm Kyowa Kirin Biologics (FKB) and Mylan’s Hulio® (adalimumab), a proposed biosimilar of Humira®; (2) Accord Healthcare’s Pelgraz® (pegfilgrastim),…
As we reported here, on June 9, 2017, Mylan filed two IPR petitions challenging Sanofi-Aventis’s U.S. Patent No. 7,476,652 (IPR2017-01528) and U.S. Patent No. 7,713,930 (IPR2017-01526), related to Sanofi’s Lantus® (insulin glargine injection). Both petitions were instituted on December 13, 2017, as reported here. On September 10, 2018, Mylan filed ten additional…
As we previously reported, a panel of the Federal Circuit in St. Regis Mohawk Tribe v. Mylan held that “tribal immunity cannot be asserted in IPRs.” The Federal Circuit’s decision, if upheld, means that Allergan’s sale and license-back of patents covering its branded product Restasis to the Tribe was ineffective in shielding the…
The European Medicines Agency (EMA) recently published highlights from the meeting of the Committee for Medicinal Products for Human Use (CHMP) on July 23-26, 2018, reporting that CHMP had adopted positive opinions, recommending the granting of marketing authorisation, for three biosimilar medicines: (1) Fujifilm Kyowa Kirin Biologics (FKB) and Mylan’s…
As we previously reported, on June 4, 2018, the U.S. FDA approved Mylan and Biocon’s Fulphila™ (pegfilgrastim-jmdb) as the first biosimilar of Neulasta® to obtain approval in the United States. Mylan stated at the time that it “anticipate[d] launching Fulphila in the coming weeks[.]” The next week, Mylan CEO Heather…
This morning, the Federal Circuit issued its much anticipated decision in St. Regis Mohawk Tribe v. Mylan Pharmaceuticals. A panel of the court, consisting of Judges Dyk, Moore, and Reyna, held that “tribal sovereign immunity cannot be asserted in IPRs.” Relying on the Supreme Court’s decisions in Oil States and SAS Institute,…
This morning AbbVie announced that it has entered into patent license agreements with Mylan over its proposed biosimilar of Humira® (adalimumab). AbbVie states that it has agreed to “grant Mylan a non-exclusive license on specified dates to AbbVie’s intellectual property relating to HUMIRA in the United States and in various…